Elemental Impurities in Drug Products; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Elemental Impurities in Drug Products.'' This guidance finalizes the draft guidance issued July 1, 2016, which provides recommendations regarding the control of elemental impurities of human drug products marketed in the United States consistent with the implementation of International Council for Harmonisation (ICH) guidance for industry entitled ``Q3D Elemental Impurities'' (ICH Q3D). This guidance will also assist manufacturers of compendial drug products in responding to the issuance of the United States Pharmacopeia (USP) requirement for the control of elemental impurities.